The FDA Will Study DTC On Branded Web Sites

Pharmalot

File this under ‘better late than never…sort of.’ Several years after the Internet took off and branded product web sites began appearing, the FDA is now getting ready to study the extent to which risk and benefit information is presented and digested. The details are expected to appear tomorrow in the Federal Register.

“This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development,” the notice reads.

Presumably, the research will be helpful, but the timing is odd. As pointed out by eyeonFDA, which first wrote about the planned study, one would think this is the sort of effort that would have been discussed at the widely attended meeting in November 2009 to discuss the impact of social media on pharmaceutical marketing. Then again, this is the same agency that continually delays issuing social media guidance (see here).

In any event, the FDA will run three studies to explore the issue. The first will investigate whether risk info on branded sites influences consumer perceptions and understanding of product risks and benefits. A second study will look at how special features such as personal testimonial videos and interactive visuals on branded sites influence perceptions and understanding of risks and benefits. And a third study will examine whether links to and citations from external organizations referenced on the homepage of branded sites influence consumer perceptions and risk info.

How will it work? Participants will be randomly assigned to view one version of a fictitious) site and, after viewing, they will answer questions about the drug. The FDA plans to test how the manipulations affect outcomes such as perceived efficacy, perceived risk, behavioral intention, and accurate understanding of the risk and benefit info. In each study, the fictitious drug will be one used for treating a “high prevalence medical condition” and modeled on an actual drug. And the participants will be consumers who have been diagnosed with the medical condition (read the notice here).